Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)

NCT ID: NCT00417378

Last Updated: 2007-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2006-03-31

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in patients with cardiogenic shock due to left ventricular failure following an acute coronary syndrome (myocardial infarction).

Detailed Description

Cardiogenic shock due to a left ventricular failure after myocardial infarction (MI) is associated with a mortality rate of 50-70 % despite all efforts such as immediate PCI of the occluded vessel, positive inotropic drugs, and the use of intraaortic balloon counterpulsation (IABP). While urgent heart transplantation or the surgical implantation of high-volume left ventricular assist devices are possible treatment options, a widespread use of these techniques for this common complication of myocardial infarction is limited. Because of the easy, percutaneous use of an intraaortic balloon pump, IABP is the method of choice for mechanical assistance in these patients. Despite a lack of randomized data, the ACC/AHA guidelines recommend the use of an intraaortic balloon counterpulsation (Level of evidence IB) in patients with a cardiogenic shock after myocardial infarction. However, improvement of the hemodynamic state by the use of an IABP is limited and the lack of an active cardiac support remains the major limitation of this treatment. Percutaneous left ventricular assist devices may both overcome the limitation of a surgical approach and offer the potential benefit of an active cardiac support during recovery of the failing left ventricle after PCI.

Previous studies have demonstrated a significant improvement of hemodynamic parameters by the use of a catheter-based miniaturized rotary blood pump (Impella LP2.5, Abiomed-Impella CardioSystems GmbH, Aachen, Germany), that is placed retrogradely through the aortic valve. The microaxial pump aspirates blood from the left ventricle and expels it to the ascending aorta with a maximal flow of 2.5 L/min. Randomized data comparing the LVAD with IABP are missing. Therefore, this trial will primarily compare the hemodynamic improvement of the LVAD (Impella LP2.5) with the hemodynamic improvement of an intraaortic balloon counterpulsation (IABP), while secondarily feasibility, safety and mortality will be compared.

Conditions

Shock, Cardiogenic; Myocardial Infarction

Keywords

ACS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

Intraaortic balloon counterpulsation (IABP)

Group Type: ACTIVE_COMPARATOR

Intraaortic Balloon Pump

Intervention Type: DEVICE

Counterpulsation

2

Left Ventricular Assist Device (Impella LP2.5)

Group Type: EXPERIMENTAL

Left Ventricular Assist Device Impella LP 2.5

Intervention Type: DEVICE

Left Ventricular Assist Device

Interventions

Left Ventricular Assist Device Impella LP 2.5

Left Ventricular Assist Device

Intervention Type: DEVICE

Intraaortic Balloon Pump

Counterpulsation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Acute coronary syndrome (ACS/AMI) < 48h and cardiogenic shock defined as:

• Clinical criteria: Hypotension (syst.BP < 90 mmHg and HR > 90/min or an AV- Block II-III) or the need for positive inotropic drugs to maintain BB > 90mm Hg)and end-organ hypoperfusion
• Hemodynamic criteria: CI < 2.2 L/min/qm and a PCWP > 15 mmHg or an EF of LV < 30% and LVEDP > 20 mmHg.
• Written informed consent of the patient or his/hers relatives

Exclusion Criteria

• Age < 18 years
• Prolonged Resuscitation (> 30min)
• Hypertrophic Obstructive Cardiomyopathy
• Thrombus in left ventricle
• Treatment with IABP
• Severe valvular disease or mechanical heart valve
• Cardiogenic Shock due to mechanical complications of myocardial infarction such as VSD, acute mitral regurgitation >II°, rupture of the ventricle
• Failure of the right ventricle defined as the need for a RV Assist Device
• Septic condition
• Cerebral Disease
• Bleeding with a need for surgical intervention
• Pulmonary embolism
• Allergy to Heparin or any known coagulopathy
• Aortic regurgitation >II°
• Pregnancy
• Inclusion in another study or trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Principal Investigators

Melchior Seyfarth, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Josef Dirschinger, MD

Role: PRINCIPAL_INVESTIGATOR

1. Medizinische Klinik, Klinikum rechts der Isar

Locations

Deutsches Herzzentrum Muenchen

Munich, , Germany

1. Medizinische Klinik, Klinikum rechts der Isar

Munich, , Germany

Countries

Germany

References

Hochman JS, Sleeper LA, Webb JG, Dzavik V, Buller CE, Aylward P, Col J, White HD; SHOCK Investigators. Early revascularization and long-term survival in cardiogenic shock complicating acute myocardial infarction. JAMA. 2006 Jun 7;295(21):2511-5. doi: 10.1001/jama.295.21.2511.

Reference Type: BACKGROUND

PMID: 16757723 (View on PubMed)

Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.

Reference Type: BACKGROUND

PMID: 10460813 (View on PubMed)

Ryan TJ, Antman EM, Brooks NH, Califf RM, Hillis LD, Hiratzka LF, Rapaport E, Riegel B, Russell RO, Smith EE 3rd, Weaver WD, Gibbons RJ, Alpert JS, Eagle KA, Gardner TJ, Garson A Jr, Gregoratos G, Ryan TJ, Smith SC Jr. 1999 update: ACC/AHA guidelines for the management of patients with acute myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol. 1999 Sep;34(3):890-911. doi: 10.1016/s0735-1097(99)00351-4. No abstract available.

Reference Type: BACKGROUND

PMID: 10483976 (View on PubMed)

Seyfarth M, Sibbing D, Bauer I, Frohlich G, Bott-Flugel L, Byrne R, Dirschinger J, Kastrati A, Schomig A. A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction. J Am Coll Cardiol. 2008 Nov 4;52(19):1584-8. doi: 10.1016/j.jacc.2008.05.065.

Reference Type: DERIVED

PMID: 19007597 (View on PubMed)

Other Identifiers

Impella M22

Identifier Type: -

Identifier Source: org_study_id